Visanne (dienogest), marketed by Bayer, is a hormonal contraceptive that is either used alone or in combination with estradiol.

In endometriosis, the medication is used to reduce pain and the size of endometrial lesions.

While Visanne is approved for the treatment of endometriosis in Europe and several countries in Latin America and the Asia-Pacific region, it has not been approved by the U.S. Food and Drug Administration (FDA).

How Visanne works

Visanne is a synthetic progesterone-like hormone (progestin). Progesterone plays a crucial role in the menstrual cycle, as it prepares the uterus for implantation. It also opposes the action of estrogen. Because estrogen stimulates the growth of endometrial lesions, progestins such as Visanne can inhibit the growth of these lesions.

Visanne in clinical trials

A randomized placebo-controlled Phase 3 clinical trial (NCT01822080) at 23 sites in China assessed the safety and efficacy of Visanne for the treatment of endometriosis. A total of 255 women with endometriosis were randomized to receive either 2 mg of oral Visanne per day or a placebo.

After 24 weeks of treatment, the pelvic pain score of the women taking Visanne was reduced by 67 percent, and by 26 percent in those taking placebo compared to the start of the trial. The treatment also resulted in an overall improvement in women’s quality of life. Visanne was well-tolerated and did not decrease bone marrow density, a common side effect of hormonal contraceptives.

Another randomized Phase 3 clinical trial (NCT00225199) assessed the efficacy and safety of Visanne compared to placebo. A total of 198 women with endometriosis-associated pelvic pain received either 2 mg oral Visanne per day or a placebo for 12 weeks.

The primary outcome was a reduction in pelvic pain, which was measured on a visual analog scale (VAS) where 0 mm represents the absence of pain, and 100 mm represents unbearable pain.

After 12 weeks of treatment, the VAS score was reduced by 27.4 mm in the Visanne group and by 15.1 mm in the placebo group, compared to the start of the trial. The difference was statistically significant. Visanne was well-tolerated with few adverse events.

The study also assessed whether the use of pain relief medication changed during the intervention. The use of supportive pain relief medication was decreased in both groups, but there was no significant difference between the groups.

A randomized clinical trial (NCT03142035) at Lebanon’s American University of Beirut Medical Center aims to compare the effect of Visanne with a GnRH receptor agonist on the fertility of women with endometriosis undergoing in-vitro fertilization (IVF). The trial is currently recruiting patients.

A Phase 4 clinical trial (NCT02575248) in Abbasia, Egypt, is also currently recruiting patients. The study aims to assess whether Visanne can improve the fertility outcome in women with stage 1 or 2 endometriosis. Participants will be randomized to receive either 2 mg of oral Visanne per day or no treatment for three months. Both groups will then receive 5 mg of clomiphene citrate for three months to induce ovulation.

Another Phase 4 clinical trial (NCT03789123) at the Bagcilar Research and Training Hospital in Istanbul, Turkey, aims to assess the effect of Visanne treatment on endometriomas or ovarian cysts. Participants will receive either Visanne alone, Visanne in combination with estradiol, or no therapy for up to 24 months. Outcome measures are ovarian reserve (number of remaining eggs in the ovaries), endometrioma size, and pain score. The trial is currently recruiting patients.

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